Internal body cavity therapeutic applicators and methods for using them

ABSTRACT

An apparatus for providing treatment to at least one tissue includes a distal balloon, a proximal balloon, and at least one intermediate balloon positioned between the distal balloon and the proximal balloon and inflatable independently from the distal and proximal balloons. A source lumen is positioned within at least the intermediate balloon receives a radiation source to treat target tissue adjacent the intermediate balloon.

TECHNICAL FIELD

The present disclosure relates to apparatus and methods for treatinginternal tissue disorders, and more particularly, to apparatus andmethods for the treatment of such disorders by direct application ofradiation therapy to areas within a patient's body.

BACKGROUND

Internal tissue disorders (e.g., cancer) can be a result ofgenetic-malformations or can arise from sickness or trauma. Suchdisorders can typically be treated, for example, with, the applicationof pharmaceuticals (e.g., directly or systemically), by the applicationof tissue altering forces (e.g., radiotherapy), or by surgicalintervention.

Where radiotherapy is the chosen treatment, it would be advantageous, tothe extent possible, to limit exposure of collateral healthy tissue tothe treatment and maximize radiotherapy treatment of the internal tissuedisorder.

SUMMARY

The following presents a simplified summary of the claimed subjectmatter in order to provide a basic understanding of some aspects of theclaimed subject matter. This summary is not an extensive overview of theclaimed subject matter. It is intended to neither identify key orcritical elements of the claimed subject matter nor delineate the scopeof the claimed subject matter. Its sole purpose is to present someconcepts of the claimed subject matter in a simplified form as a preludeto the more detailed description that is presented later.

An apparatus for providing treatment to at least one tissue includes adistal balloon, a proximal balloon, and at least one intermediateballoon positioned between the distal balloon and the proximal balloonand inflatable independently from the distal and proximal balloons. Asource lumen positioned within at least the intermediate balloonreceives a radiation source to treat target tissue adjacent theintermediate balloon.

By providing independently inflatable balloons, applicators inaccordance with the present disclosure allow a radiation dose to bemaximally applied to the internal tissue disorder, and yet minimallyapplied to the surrounding area, thus limiting the patient's adjacenthealthy tissue to unnecessary exposure to the radiation, as well as anypossible side effects.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more other technical advantages maybe readily apparent to those skilled in the art from the figures,descriptions, and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some, or none of the enumerated advantages.

Further scope of applicability of the present disclosure will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating specific embodiments of the presentdisclosure, are given by way of illustration only, since various changesand modifications within the spirit and scope of the present disclosurewill become apparent to those skilled in the art from this detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the presentdisclosure will become more apparent in light of the following detaileddescription when taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a side view of an exemplary applicator according to anexemplary embodiment of the present disclosure;

FIG. 2 is an enlarged side view of the distal or treatment end of theexemplary applicator according to FIG. 1;

FIG. 3 is perspective view of a hub of the exemplary applicatoraccording to FIG. 1;

FIG. 4 is cross-sectional view through the flexible elongated shaft ofthe exemplary applicator according to FIG. 1;

FIGS. 5A and 5B are cross sectional views of the outer body of the huband the hub insert, respectively, of the exemplary applicator accordingto FIG. 1;

FIG. 6 is a perspective view of the hub of the exemplary applicatoraccording to FIG. 1 with the outer body being formed from a transparentmaterial, the hub insert partially inserted into the outer body, and theproximal end of the flexible elongated shaft inserted into the distalopening of the outer body;

FIG. 7 is a cross-sectional view of the exemplary applicator accordingto FIG. 1 showing the outer body being assembled with the hub insertwith coupling tubes in place coupling the inflation and guide lumens tothe flexible elongated shaft;

FIG. 8 is an enlarged side cross-sectional view of the exemplaryapplicator according to FIG. 1 positioned within tubular body tissue;

FIG. 9 is a side view of the exemplary applicator according to FIG. 1positioned within tubular body tissue with all balloons inflated; and

FIG. 10 is a cross-sectional view through the distal end of anotherexemplary applicator according to the present disclosure.

The figures depict specific embodiments of the present disclosure forpurposes of illustration only. One skilled in the art will readilyrecognize from the following discussion that alternative embodiments ofthe structures and methods illustrated herein may be employed withoutdeparting from the principles of the present disclosure describedherein.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are describedhereinbelow with reference to the accompanying drawings; however, it isto be understood that the disclosed embodiments are merely exemplary andmay be embodied in various forms. Well-known functions or constructionsare not described in detail to avoid obscuring the present disclosure inunnecessary detail. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the presentdisclosure in virtually any appropriately detailed structure.

Like reference numerals may refer to similar or identical elementsthroughout the description of the figures. As shown in the drawings anddescribed throughout the following description, as is traditional whenreferring to relative positioning on a surgical instrument, the term“proximal” refers to the end of the apparatus which is closer to theuser and the term “distal” refers to the end of the apparatus which isfarther away from the user. The term “clinician” refers to any medicalprofessional (i.e., doctor, surgeon, nurse, or the like) performing amedical procedure involving the use of embodiments described herein.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. The word “example” may be usedinterchangeably with the term “exemplary.”

Reference will now be made in detail to embodiments of the presentdisclosure. While certain embodiments of the present disclosure will bedescribed, it will be understood that it is not intended to limit theembodiments of the present disclosure to those described embodiments. Tothe contrary, reference to embodiments of the present disclosure isintended to cover alternatives, modifications, and equivalents as may beincluded within the spirit and scope of the embodiments of the presentdisclosure as defined by the appended claims.

The exemplary embodiments of the present disclosure relate to anapplicator that can be used to treat internal tissue disorders bytargeting radiotherapy treatments directly to the internal tissuedisorder. For example, the exemplary applicator can use a plurality ofballoons, only some of which are inflated, to provide the treatmentdirectly to the disorder depending on where adjacent the tubularstructure the disorder is located. Those having ordinary skill in theart will understand that the exemplary embodiments of the presentdisclosure can be implemented in any tubular structure in the body of apatient (e.g., the rectum, the nose, the lungs, the GI track, vascularsystem, the esophagus, etc).

FIG. 1 shows a side view of an exemplary applicator/arrangementapparatus 100 according to an exemplary embodiment of the presentdisclosure in an inflated form, for delivering treatment to an internaltissue disorder. Exemplary applicator 100 has a distal or treatmentportion 105 configured to be inserted into the tubular structure, aflexible elongated shaft 115, a proximal portion 125 (e.g., inflationlumens, source lumen and guide wire lumen), and a hub 130 positionedbetween the proximal end of flexible elongated shaft 115 and proximalportion 125. A source lumen 145 extends from proximal portion 125through the center of applicator 100 to distal portion 105. Inembodiments, a guide lumen 150 also extends from proximal portion 125through the center of applicator 100 to distal portion 105.

Distal portion 105 can include a tip 140 which can be configured to aidin the insertion of applicator 100 into the tubular structure and trackon the guide wire. For example, tip 140 can taper distally to a widthsmaller than the width of distal portion 105, and can increase in sizeproximally. Distal tip 140 may also include a marker 142 (FIG. 2) thatis visible to an imaging system (not shown) to confirm accurateplacement of the applicator 100 relative to tissue to be treated. Inembodiments, marker 142 is a radiopaque marker. Optionally, a lubricant(e.g., liquid, gel or the like), is used to aid insertion into a tubularstructure by inserting tip 140 into the tubular structure.

Referring to FIGS. 1 and 2, distal portion 105 can include a pluralityof balloons 120 a-120 e located on distal portion 105 with bands orrings 122 a-122 d provided between adjacent balloons. One or more ofrings 122 a-122 d may also include a marker that is visible to animaging system (such as, for example, MRI, x-ray, fluoroscopy and/orultrasound, not shown) to confirm accurate placement of the balloons 120a-120 e relative to tissue to be treated. In embodiments, each ofballoons 120 a-120 e can be individually inflated. In embodiments, twoor more of balloons 120 a-120 e can be simultaneously inflated. Inembodiments, a first and third balloon may be inflated while a secondballoon positioned between the first and the third balloon remainsuninflated. Balloons 120 a-120 e may each be the same size or, inembodiments, one or more of balloons 120 a-120 e may be of a differentsize than others of balloons 120 a-120 e. Generally, the size of eachballoon will be tailored to the size of the tubular structure into whichthe applicator is being inserted. (FIG. 10) Generally, the balloons maybe from 0.1 cm to 10 cm in diameter, in other embodiments from 1 cm to 5cm in diameter. In embodiments where the applicator is intended forinsertion into the esophagus, the balloons may be from 1.5 cm to 3.5 cmin diameter. Balloons 120 a-120 e can be fabricated from anybiocompatible material capable of inflation. In embodiments, thematerial from which balloons 120 a-120 e are constructed is elastic. Thematerial from which balloons 120 a-120 e are constructed may be a singlelayer or may be a laminate material. Those skilled in the art willreadily envision suitable materials for use in making balloons 120 a-120e. While the applicator in the exemplary embodiment of FIG. 1 includesfive balloons, it should of course be understood that applicators inaccordance with other exemplary embodiments may include three, four,five, six, seven, or even more balloons.

Elongated shaft 115 may include one or more markers 117 that are visibleto an imaging system (such as, for example, MRI, x-ray, fluoroscopyand/or ultrasound, not shown) to confirm accurate placement of theapplicator relative to tissue to be treated. Elongated shaft 115 mayalso or instead include one or more numerical indicia 119 to indicate tothe clinician the depth to which applicator 100 has been inserted intothe tubular structure of the body. Generally, elongated shaft 115 may befrom 20 cm to 100 cm in length, in embodiments from 25 cm to 50 cm inlength. In embodiments where the applicator is intended for insertioninto the esophagus, the elongated shaft may be from 15 cm to 45 cm inlength.

In embodiments where each of balloons 120 a-120 e are individuallyinflatable, a series of inflation lumens 126 a-126 e are provided. Eachinflation lumen 126 a-126 e is provided with a stopcock valve 127 a-127e at the proximal end thereof. Inflation lumens 126 a-126 e beginadjacent the proximal end with stopcock-capped tubes, the distal ends ofwhich are received within hub 130 such that lumens 126 a-126 c extendthrough hub 130, and continue along the length of flexible elongatedshaft 115 to distal portion 105 of applicator 100 where the distal endof each of lumens 126 a-126 e opens into one of respective balloons 120a-120 e. Inflation fluid may be any suitable fluid, either a gas or aliquid, and is typically inert. Inflation fluid, where a gas, may be,e.g., air, nitrogen, carbon dioxide or other gas. Inflation fluid, wherea liquid, may be water, saline, mineral oil, or other liquid. Inembodiments, an inflation fluid may be effective to absorb radiation to,for example, shield, moderate or adjust a dosage of radiation deliveredto a patient's tissue from radioactive treatment material containedwithin source lumen 145.

Guide lumen 150 can be used to slide the applicator 100 over a guide(e.g., cable and/or wire, not shown), for example, from a proximal to adistal location after the guide (not shown) is placed. Alternately or inaddition, exemplary applicator 100 can be introduced independently orcan be fixed to an endoscope, cable, or guide wire, and can beintroduced simultaneously with the endoscope, cable or guide wireplacement at the treatment site.

Source lumen 145 can be used to deliver an intended treatment to thesite of the tissue to be treated. In embodiments, source lumen 145 isused to deliver radiotherapy, such as, for example brachytherapy, totissue to be treated. As those skilled in the art will appreciate, thereare two defined brachytherapy categories: low dose rate (LDR)brachytherapy and high dose rate (HDR) brachytherapy. The two differ indose rates of radioisotopes and treatment strategies. Commonradioisotopes for LDR brachytherapy include iodine-125 (¹²⁵I) andpalladium-103 (¹⁰³Pd), whereas gold-198 (¹⁹⁸Au) and iridium-192 (¹⁹²Ir)are among the radioisotopes for HDR treatment. Those skilled in the artreading the present disclosure will readily envision other therapiesthat can be delivered using an applicator in accordance with the presentdisclosure.

Prior to application of the therapeutic material through source lumen145, lumen 145 may be used to accommodate a removable stiffening mandrelproviding added rigidity during device insertion. Once the applicator isproperly positioned, the stiffening mandrel may be removed to allowdelivery of the therapeutic material through source lumen 145.

Hub 130 facilitates the connection of the various lumens (126 a-126 e,145, 150) with flexible elongated shaft 115. The complexity of the multilumen catheter design makes injection molding of a suitable hubdifficult due to the converging angle of the inflation lumens and themulti-lumen catheter shaft. In the exemplary embodiment illustrated inthe drawings, hub 130 includes an outer body 160 and an insert 170 asshown in FIGS. 5A, 5B, 6 and 7. The design of the exemplary embodimentillustrated in the drawings has divided the internal features of thehub, with outer body 160 having the outer portion of the inner featuresand hub insert 170 having the inner portion of the inner featuresadvantageously permitting injection molding of the components of hub 130despite the presence of complex internal features. The design of theexemplary embodiment illustrated in the drawings also facilitates theassembly of flexible elongate shaft 115 with the external tubing of thevarious lumens (126 a-126 e, 150). The design of the exemplaryembodiment illustrated in the drawings also facilitates the alignment ofthe external tubing of the various lumens (126 a-126 c, 150) with thechanneled features of hub 130.

The outer body 160 of hub 130 includes a distal portion 161 having anopening 164 adapted and configured to receive the proximal end offlexible elongated shaft 115. Glue channels 163 receive glue to securethe proximal end of flexible elongated shaft 115 within opening 164. Itshould of course be understood that the proximal end of flexibleelongated shaft 115 may be secured within opening 164 using othertechniques within the purview of one skilled in the art including, butnot limited to, ultrasonic welding, friction fit, etc. Outer body 160 ofhub 130 includes a proximal portion 162 having channels 166 formed onthe inner surface thereof which are adapted and configured to receivethe respective distal ends of inflation lumens 126 a-126 e. Gluechannels 168 receive glue to secure the distal ends of inflation lumens126 a-126 e within channels 166. It should of course be understood thatthe distal ends of inflation lumens 126 a-126 e may be secured withinchannels 166 using other techniques within the purview of one skilled inthe art. Channels 166 step down in size to channels 167 which areadapted and configured to receive coupling tubes 186. The distal ends169 of channels 167 align with the various lumens in flexible elongatedshaft 115. Channel 169 is provided in hub outer body 160 and is adaptedand configured to receive the distal end of guide lumen 150.

Hub insert 170 includes channels 176 formed on the inner surface thereofwhich are adapted and configured to receive respective distal ends ofinflation lumens 126 a-126 c. Channels 176 step down in size to channels177 which are adapted and configured to receive coupling tubes 186.Channel 178 is provided in hub insert 170 and is adapted and configuredto receive the distal ends of guide lumen 150. Hub insert 170 alsoincludes travel stops 179 which seat against the distal end of channels166 in outer body 160 when the hub insert 170 is assembled with outerbody 160.

As those skilled in the art will appreciate, channels 166, 176 cooperateto surround distal ends of inflation lumens 126 a-126 e which are placedover the proximal ends of coupling tubes 186 when the applicator 100 isassembled. In like manner, channels 167, 177 cooperate to surrounddistal ends of coupling tubes 186 when the applicator 100 is assembled.Distal ends of coupling tubes 186 are positioned within thecorresponding lumen in flexible elongated shaft 115 as shown in FIG. 7.

In an exemplary method of using an applicator in accordance with thepresent disclosure, a clinician inserts the applicator into the tubularbody tissue with all balloons deflated. Once positioned adjacent tissueto be treated using clinical medical imaging technology, one or more ofthe balloons are inflated with fluid by the clinician by attaching asyringe or other fluid supply to the stopcock valves at the distal endof the inflation lumens corresponding to balloons to be inflated. Whenthe desired number of balloons are inflated to the desired diameter, atherapy source is advanced through the source lumen to deliver therapyto the tissue to be treated. Exemplary applicator 100 can be designedsuch that any radiation source can be inserted into source lumen 145,including multiple radiations sources at a time. The radiation sourcecan be positioned in source lumen 145 and appropriate balloons inflatedsuch that a radiation dose can be maximally applied to the internaltissue disorder, and yet minimally applied to the surrounding area, thuslimiting the patient's healthy tissue to exposure to radiation, and anypossible collateral side effects. A radiation source may be positionedwithin source lumen 145 using suitable techniques, including but notlimited to manual or remote afterloading. As those skilled in the artwill appreciate, remote afterloading systems provide protection fromradiation exposure to healthcare professionals by securing the radiationsource in a shielded safe. Once the applicator is correctly positionedin the patient, the applicator is connected to a commercially available‘afterloader’ machine (containing the radioactive sources) throughsource lumen 145. A treatment plan is programmed into the afterloader,which then controls the delivery of the radiation source along thesource lumen into the pre-specified position within the applicator. Theradiation source remains in place for a pre-specified length of time,again following the treatment plan, following which the radiation sourceis returned along the source lumen to the afterloader. On completion ofdelivery of the radioactive source, the applicator is carefully removedfrom the body.

In the exemplary method illustrated in FIG. 8, after applicator 100 isinserted to the desired position within tubular body tissue “T”,distalmost balloon 120 a is inflated, balloon 120 b immediately proximalof balloon 120 a remains uninflated, and the next proximal balloon 120 cis inflated. In this manner, target tissue to be treated (e.g., tumortissue “TT”) is approximated more closely to the radiation sourcepresent in source lumen 145 at the center of applicator 100 by virtue ofthe fact that balloon 120 b is uninflated, while adjacent healthy tissue(“HT” in FIG. 6) remains further from the radiation source. In thismanner, applicators in accordance with the present disclosure providefor improved radiation dose conformity compared to previously knownapplicators. It should be understood that balloons 120 a and 120 c canbe individually inflated or may be connected to the same inflation lumenso that both balloons 120 a, 120 c are simultaneously inflated. Itshould also be understood that the ability to achieve individualinflation provides the clinician with maximum flexibility with respectto exposing only the intended target tissue to the therapeutic levels ofradiotherapy while reducing collateral exposure of healthy tissue toradiation. It should also be understood that any combination of balloonsmay be inflated and remain uninflated. For example, balloon 120 a and120 e may be inflated while balloons 120 b-102 d all remain uninflated.Alternatively, balloons 120 a, 102 b and 120 e may be inflated whileballoons 120 c and 102 d remain uninflated. In other embodiments of thepresent methods, balloons 120 a, 102 d and 120 e may be inflated whileballoons 120 b and 102 c remain uninflated. Alternatively, balloons 120a and 120 c may be inflated while balloons 120 b and 102 d and 102eremain uninflated. Other combinations of inflation/uninflation will beapparent to those skilled in the art reading this disclosure.

Typical catheters will have contact points on a curved anatomy at theouter wall of the lead into to the curve and at the apex of the curve.These contact points would not allow uniform circumferential applicationof the radiation dose. The presently described applicator havingmultiple individually inflatable balloons in close proximity enables thesource lumen to be centered in the curved anatomy as shown in FIG. 9.The ability to inflate the balloons individually allows the applicationof relatively equal force to the curved anatomy thereby centering thesource lumen and resulting in a more uniform circumferential exposure.As those skilled in the art will appreciate, if the balloons were to beinflated simultaneously the pressure of one balloon in the curve wouldforce the outer balloons to inflate first and to larger diameter thanthe balloon in the apex.

FIG. 10 shows a cross-sectional view of an applicator 100 according toan exemplary embodiment of the present disclosure in an inflated form,for delivering treatment to an internal tissue disorder. Exemplaryapplicator 200 has a distal or treatment portion 205 that can beinserted into the tubular structure and a flexible elongated shaft 215.Exemplary applicator 200 also includes a proximal portion (not shown),and a hub (not shown) that are similar in structure and function tothose described in connection with the exemplary embodiment of FIG. 1.Source lumen 245 extends through the center of applicator 200 to distalportion 205.

The exemplary embodiment shown in FIG. 10 includes four balloons, 220a-202 d, with distalmost balloon 220 a being larger that balloons 220b-220 d. Distalmost balloon 220 a can also serve to anchor theapplicator within the tubular body structure, with balloons 220 b-220 dfunctioning as shown by balloons 120 a-120 c in FIG. 6.

The various components of the applicators described herein can be madeof any sterilizable material. In embodiments, all components of theapplicators described herein arc made of MRI compatible materials. It isfurther contemplated that some or all of the components can be made oftransparent materials, (such as is shown in FIG. 6 with respect to outerbody 160 of hub 130) to allow visual confirmation of fluids passingthrough the various lumens.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of presently disclosed embodiments. Thus the scope ofthe embodiments should be determined by the appended claims and theirlegal equivalents, rather than by the examples given.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. The featuresillustrated or described in connection with one exemplary embodiment maybe combined with the features of other embodiments. Such modificationsand variations are intended to be included within the scope of thepresent disclosure. As well, one skilled in the art will appreciatefurther features and advantages of the present disclosure based on theabove-described embodiments. Accordingly, the present disclosure is notto be limited by what has been particularly shown and described, exceptas indicated by the appended claims.

It should be understood that the foregoing description is onlyillustrative of the present disclosure. Various alternatives andmodifications can be devised by those skilled in the art withoutdeparting from the disclosure. Accordingly, the present disclosure isintended to embrace all such alternatives, modifications and variances.The embodiments described with reference to the attached drawing figs.are presented only to demonstrate certain examples of the disclosure.Other elements, steps, methods and techniques that are insubstantiallydifferent from those described above and/or in the appended claims arealso intended to be within the scope of the disclosure.

1. An apparatus for providing treatment to at least one tissue,comprising: a distal balloon; a proximal balloon; and at least oneintermediate balloon positioned between the distal balloon and theproximal balloon, the at least one intermediate balloon being inflatableindependently from the distal and proximal balloons; a source lumenadapted and configured to receive a radiation source, the source lumenpositioned within at least the at least one intermediate balloon.
 2. Theapparatus of claim 1 wherein the distal and proximal balloons are eachindependently inflatable.
 3. The apparatus of claim 1 wherein at leastone of the distal, at least one intermediate and proximal balloons has adiameter different from the other of the distal, at least oneintermediate and proximal balloons. 4-7. (canceled)
 8. A method ofproviding treatment to at least one tissue, the method comprising:positioning the at least one intermediate balloon of the apparatus ofclaim 1 adjacent tissue to be treated; inflating one or more of thedistal balloon, the at least one intermediate balloon, or the proximalballoon; and inserting a radiation source via the source lumen within atleast the at least one intermediate balloon to expose the tissue to betreated to radiation. 9-13. (canceled)
 14. A hub for use with amulti-lumen applicator comprising: an outer body having a longitudinalaxis and an inner surface defining a first portion of a plurality oflongitudinally extending channels, the outer body further defining acentral opening adjacent a distal portion thereof; an insert having anouter surface defining a second portion of the plurality oflongitudinally extending channels, the insert configured to be matinglyreceived within the outer body such that, when assembled, the outer bodyand insert together define the plurality of longitudinally extendingchannels extending from a proximal end of the hub to the central openingof the outer body.
 15. The hub of claim 14 wherein the central openingof the outer body is configured and dimensioned to receive an elongateshaft having a plurality of longitudinally extending lumens such thatthe plurality of longitudinally extending lumens are in registeredalignment with the longitudinally extending channels defined by thecombined outer body and insert.
 16. The hub of claim 14 wherein theinsert defines at least one travel stop configured to abut correspondingstructure defined in the inner surface of the outer body to align theinsert within the outer body.
 17. The hub of claim 14 wherein theplurality of longitudinally extending channels defined by the outer bodyand insert are substantially fluid tight when the outer body and insertare assembled.
 18. The hub of claim 14 wherein a proximal end of one ormore of the plurality of longitudinally extending channels is configuredto receive a respective inflation lumen.
 19. The hub of claim 14 whereinone of the plurality of longitudinally extending channels is configuredto receive a guide lumen.
 20. The hub of claim 18 wherein the one ormore of the plurality of longitudinally extending channels configuredreceive a respective inflation lumen are further configured to receivecoupling tubes adapted to connect to the inflation lumen.
 21. The hub ofclaim 14 wherein the insert defines a longitudinally extending sourcelumen.
 22. A hub for interconnecting a plurality of lumens to a shaft,the hub comprising: an outer body having a longitudinal axis and havingan inner surface defining an outer portion of a radial array of lumens;and an insert having an outer surface defining an inner portion of theradial array of lumens, the insert configured and dimensioned to fitwithin the outer body to form a radial array of complete lumens, whereinthe outer body further defines a central opening adjacent a distalportion thereof in fluid communication with the radial array of lumens.23. The hub of claim 22 wherein at least one lumen of the radial arrayof lumens defines a first diameter adjacent a proximal portion of theouter body and converges to a smaller diameter as it extends toward thecentral opening of the outer body.
 24. The hub of claim 22 wherein aninner surface of the central opening is configured and dimensioned toreceive a proximal end of an elongate shaft with a plurality oflongitudinally extending lumen, the lumen in the shaft being in fluidcommunication with the radial array of lumens formed by the outer bodyand the insert.
 25. The hub of claim 22 wherein proximal ends of theradial array of lumens formed by the outer body and the insert areconfigured and dimensioned to connect to respective coupling tubes. 26.The hub of claim 22 wherein the insert further defines a source lumen.27. The hub of claim 22 wherein an inner surface of the central openingof the outer body includes structure to facilitate attachment of anelongate shaft therein.
 28. The hub of claim 27 wherein the structureincludes at least one glue channel.
 29. The hub of claim 22 wherein theinsert further includes travel stops which cooperate with the innersurface of the outer housing.